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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Based on the test result for acute oral toxicity, the tested substance is considered as not toxic for oral route with a LD50 > 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
other: experimental study on similar substance
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Full article with few details on results
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
not specified
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
The test material was supplied by Tokyo Kasei Kogyo Industry Ltd, Tokyo Japan.
Species:
other: mice
Strain:
other: ddY
Sex:
male
Details on test animals or test system and environmental conditions:
4 Male ddY mice were obtained from Japan SLC Co., Shizuoka, Japan, at 7 weeks of age and used after 1 week of acclimatization.
They were fed commercial pellets MF (Oriental Yeast Industries Co., Tokyo, Japan) and tap water ad libitum throughout the acclimatization period and the experiment.
The animal room was at 20–24 ◦C with a 12 h light–dark cycle.
Route of administration:
oral: unspecified
Vehicle:
other: saline solution
Details on oral exposure:
The test substance were dissolved in saline solution.
Doses:
All food additives were administered orally at up to 0.5 × LD50 or the limit dose of 2000 mg/kg.
No. of animals per sex per dose:
4
Control animals:
not specified
Preliminary study:
-
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

Based on the test results, no toxic effect were seen for an oral application of the tested substance.

No death occurred during the fixed dose test.

Endpoint:
acute toxicity: oral
Type of information:
other: experimental study on similar substance
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: publication with many details on test procedure and results
Qualifier:
equivalent or similar to guideline
Guideline:
other: Toxicity test performed on pigs for 76 days
Deviations:
not specified
Principles of method if other than guideline:
Similar to Short term repeated test on pigs for 21 days.
GLP compliance:
not specified
Test type:
other: 76 days of exposure
Limit test:
no
Species:
pig
Strain:
other: SPF Danish Landrace
Sex:
male/female
Details on test animals or test system and environmental conditions:
36 pigs after an accomodation period of 21 days, were distributed according to body weight into 9 groups of 2 males and 2 females.

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All pigs were dosed by gavage 3 h after feeding in the morning.
The doses administered were rather high and were adjusted in relation to how well they were tolerated as judged by clinical and hematological examination.
Doses:
1000 From 1st to 21st day and 1500 mg/kg bw from 22nd to 76th day.
No. of animals per sex per dose:
9 groups of 2 males and 2 females
Control animals:
yes
Remarks:
untreated
Details on study design:
Bodyweight was recorded weekly and food intake daily.
Preliminary study:
-
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 500 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
The azo dye produced no significant effect on the clinical and hematological parameters.
Gross pathology:
No effects were seen for the tested substance.
Other findings:
Blood samples were collected from all animals from truncus jugularis 2 days prior to and 5, 19 and 68 days following the start of the dosing period.
On clinical indication further blood samples were collected from single animals.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 is > 1500 mg/kg bw
Executive summary:

None of the tested azo dyes produced any significant toxic effects on the examined liver and blood parameters on pigs after an oral application of 76 day.

Endpoint:
acute toxicity: oral
Type of information:
other: experimental study on similar substance
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: HPV program
Qualifier:
no guideline available
Principles of method if other than guideline:
Acute oral toxicity test on dogs
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
dog
Strain:
other: Mongrel dogs
Sex:
male
Details on test animals or test system and environmental conditions:
Each test animal was individually housed. Food and water were available ad libitum.
Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
2 male dogs
Control animals:
yes
Remarks:
300 ml of water
Details on study design:
Observations were made immediately following dosing and daily thereafter for 7 days.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths at the dose level tested (5000 mg/kg bw).
Clinical signs:
Red diarrhea was observed 30 minutes following dosing in one animal, which was followed by emesis. Red urine was reported for the other animal. Red stools were reported for both dogs one day following dosing.
Body weight:
From the third day until the seventh day, both animals appeared normal with respect to appetite.
Gross pathology:
Gross necropsy revealed fibrotic changes and decreased weight in a kidney of one test animal. This finding was not considered treatment-related but was rather considered to be a chronic lesion. The spleen also appeared enlarged in this test animal.
Other findings:
From the third day until the seventh day, both animals appeared normal with respect to appearance, behavior, appetite and elimination.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

The tested substance does not show toxic effect on oral application of 5000 mg/kg bw to two male dogs.

Endpoint:
acute toxicity: oral
Type of information:
other: experimental study on similar substance
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: HPV program
Qualifier:
no guideline available
Principles of method if other than guideline:
Acute oral toxicity test on rats
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
The animals were housed in metal cages suspended above the droppings. Food and water were available ad libitum.
Six groups of 5 males and 5 females.
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
215, 464, 1000, 2150, 4640, and 10,000 mg/kg bw.
No. of animals per sex per dose:
4 male and 4 females rats
Control animals:
not specified
Details on study design:
Observations were made immediately following dosing, at 1, 4, 24, 48 hours and once daily thereafter up to 14 days
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths at the dose level tested.
Clinical signs:
Clinical observations were normal with the exception of red-colored feces in both sexes at all dose levels and red-colored urine at the three highest dose levels in the female animals.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 10000 mg/kg bw
Executive summary:

The tested substance does not show toxic effect on oral application to six groups of 5 male and 5 female rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

There are different test performed on similar substance related to oral toxicity.
One test was performed following OECD 420 showed a LD50 > 1000 mg/kg since it was the highest tested dose.
Some other subacute studies are available performed on different animals with the following results:
LD50 rats > 10000 mg/kg bw
LD50 dogs > 5000 mg/kb bw
LD50 pigs > 1500 mg/kg bw

Based on the available results, the LD50 of the tested substance was fixed to > 2000 mg/kg bw.

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be greater than 2000 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.